Covidien

INVOS Cerebral Oximeters

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Cleaning, Disinfection and Sterilization Protocols Patient Monitoring Aug 2020

Preamplifiers For use with INVOS System, Model 5100C... Reordering Information: Reorder from Covidien at 800-635-5267, in the U... or online at www... vidien... m 0123 Covidien llc 15 Hampshire Street Mansfield, MA 02048 USA Ph: 800-635-5267 www... vidien... m Models 5100C-PA and 5100C-PB Close preamp locking mechanism down over cables once inserted... See Operations Manual for additional instructions Covidien Ireland Limited, IDA Business & Technology Park, Tullamore... © 2011 Covidien... omanetics, INVOS, SomaSensor, OxyAlert NIRSensor, “Reflecting the color of life,”“Area Under the Curve,” AUC, “Enlightening Medicine” and “Window to the Brain” are trademarks of a Covidien companyTrademarks, all product packaging and logos are protected by trademark rights, copyrights and other rights owned by a Covidien company... ther trademarks belong to their respective owners... P/N 314148 Rev...

INVOS 5100C-PA and PB Preamplifiers Quick Setup Guide Rev C

INVOS 5100C System TM Operations Manual Supplement Cumulative Saturation Below Threshold (AUC) Trend Line Averaging EN US FR Instructions For Use Mode d’emploi DE Gebrauchsanweisung NL Gebruiksaanwijzing IT Istruzioni per l’uso ES Instrucciones de uso SV Bruksanvisning DA Brugsanvisning NO Bruksanvisning FI Käyttöohjeet PT Instruções de uso RU Инструкция по применению EL Οδηγίες χρήσης CZ Návod k použití PL Instrukcja użytkowania HU Használati útmutató TR Kullanma Talimatı C SKS RO Návod na použitie Instrucţiuni de utilizare EN US INVOS 5100C System Operations Manual Supplement Cumulative Saturation Below Threshold (AUC) and Trend Line Averaging (English GB) For use with INVOS® 5100C System ONLY Cumulative saturation below threshold (AUC) and Trend Line Averaging may now be calculated and displayed on the INVOS System... or additional information regarding warnings, precautions, indications for use, setup and use of the INVOS System, consult the Operations Manual... INVOS SYSTEM APPLICATION SOFTWARE Application software that contains Cumulative Saturation Below Threshold (AUC) and Trend Line Averaging additional features begins with software versions 7... 01 or greater... oftware upgrades are performed using a USB Flash Drive supplied by Covidien... o inquire about software upgrades contact Covidien’s Customer Service Department by Email Customer... rvice-RMS@covidien... m or via the Internet at www... vidien... m or your local representative... SB Flash Drives supplied by Covidien are accompanied by Software Upgrade Instructions For Use... OTE: Prior to installing the software, it is recommended that all patient files in the case archive list be downloaded and archived and the files be deleted from the case archive file list... atient files created prior to installing the new software will not be able to be viewed or downloaded once the installation is completed... OTE: Cumulative saturation below threshold (AUC) may now be calculated and displayed in Normal Mode... reviously, this capability was available to those centers using the Database Operational Mode software to submit data to the STS Adult Cardiac Database... o inquire about the Database Operational Mode versions of application software and Database Operational Mode access, contact Covidien’s Customer Service Department... OTE: AUC in Normal Mode cannot be used in combination with the Database Operational Mode... DEFINITIONS FOR AUC AND TREND LINE AVERAGING Cumulative Saturation Below Threshold (AUC) indicates the cumulative integral of time and depth of desaturation events below the threshold of 75% of the baseline rSO2 value (relative decline of 25% below baseline) for rSO2... alculated by the cerebral oximeter by multiplying the difference between the threshold and current rSO2 values times the duration that rSO2 is below the threshold... alues are accumulated throughout the operation... nits are minute-%... rend Line Averaging calculates a 60 minute rolling average of rSO2 by averaging the non-zero data recorded over the last one hour time period for each channel being monitored... iewing a 60 minute rolling average of rSO2 is useful in clinical situations where there is frequent and wide variability in rSO2 values... n some situations this erratic nature of the physiologic measurement can make it difficult to recognize important progressive changes in perfusion... his scenario is best illustrated when monitoring gastro-intestinal O2 delivery (G-rSO2) in the neonate... he characteristic of G-rSO2 is widely variable and difficult to interpret and of little value on a real time basis... owever, progressive changes over longer periods of time may be more indicative of the status of the gastrointestinal region... eal-time rSO2 values and alarms are always displayed in normal fashion on the INVOS screen for the clinician when using the Trend Line Averaging feature... OPERATING Cumulative Saturation Below Threshold (AUC) in Normal Mode Normal Mode AUC enables the calculation of AUC from user selectable thresholds, either a % below baseline or a fixed value... ith this threshold flexibility, users may quantify desaturation in a wide range of cerebral and somatic applications... UC can be calculated for the time a channel’s value is below a fixed threshold ranging from 30 to 60% in increments of 5% or a percentage below Baseline (ranging from 0 to 30% in increments of 5%... he AUC in Normal Mode default settings are for the feature to be disabled, or when enabled, 25% below Baseline... UC calculates the Area Under the Curve for all channels being monitored and displays on the monitor simultaneously with the real time rSO2... he units of AUC are minutes %... hen Percentage Below Baseline is selected for Normal Mode AUC calculations, the Normal Mode AUC is acculmulated for each channel being monitored for the duration of time the current rSO2 value is nonzero and less than the value calculated by the formula: Baseline X (1 – Percent below Baseline setting)... hen Fixed rSO2 Threshold is selected for Normal Mode AUC calculations, the Normal Mode AUC is calculated on all channels being monitored for the duration of time the current rSO2 value is non-zero and less than the fixed rSO2 Threshold setting... o enable or disable the Normal Mode Area Under the Curve, press the HOME key to display the Main Screen, then follow these navigation bar options: BASELINE MENU EVENT MARK ALARM AUDIO ON/OFF NEXT MENU OUTPUT SELECT USER CONFIGURATION TIME SCALE NEXT MENU NEXT PREVIOUS OFF ON NEXT PREVIOUS INCREASE DECREASE NEXT PREVIOUS INCREASE DECREASE In the User Configuration Menu, select NEXT to scroll to NORMAL MODE AUC... elect OFF, FIXED or % BELOW BASELINE option... f FIXED or % BELOW BASELINE option is selected, select NEXT and select a preferred threshold... he User Configuration Screen consists of three pages, displaying settings for parameters such as Normal Mode AUC that the operator can change (See Figure 1 User Configuration Screens, found at back of manual supplement)... hen finished, press the HOME key to exit the User Configuration Menu and return to the Main Screen... n the Main Screen, characters appear to the left of the real-time rSO2 value... UC is displayed on the Main Screen in the Data Channel Area in place of rSO2 Relative (%) change from Baseline, under the Real-Time rSO2 Values (See Figure 2 Main Screen, found at back of manual supplement displaying AUC)... 2

INVOS 5100C System Operations Manual Supplement Rev B

Reusable Sensor Cable Models RSC-1, RSC-2, RSC-3 and RSC-4 DO NOT DISCARD! Reusable Sensor Cables are intended for multiple use... or use with SomaSensor Models SAFB-SM and SPFB... Sensor is designed for single-patient use... euse of the sensor may cause inaccurate readings... Close preamp locking mechanism down over cables once inserted... lue clip can join together two cables... Reordering Information: Reorder from Covidien at 800-635-5267 or www... vidien... m... 123 See SomaSensor Instructions For Use inside carton Covidien llc 15 Hampshire Street • Mansfield, MA 02048 USA 800... 5... 67 www... vidien... m Covidien Ireland Limited IDA Business & Technology Park • Tullamore © 2011 Covidien... omanetics, INVOS, SomaSensor, OxyAlert NIRSensor, “Reflecting the color of life,”“Area Under the Curve,” AUC, “Enlightening Medicine” and “Window to the Brain” are trademarks of a Covidien company... rademarks, all product packaging and logos are protected by trademark rights, copyrights and other rights owned by a Covidien company... ther trademarks belong to their respective owners... /N 314146 Rev...

INVOS Models RSC- x series Resuable Sensor Quick Guide Rev C

INVOS 5100C System Operations Manual Table of Contents Description of Symbols... ii Table of Contents... v Chapter 1 Warnings/Cautions 1... Key Terms ... 1... Warnings ... 1... Precautions... 1... Indications For Use... 1... Contraindications... Chapter 2 Before You Begin 2... Chapter Overview... 5 2... How to Use this Manual... 5 2... Application of the INVOS System... 2... SomaSensor® and OxyAlert™ NIRSensor... 2... Use of Product... 6 2... Customer Inquiries... 2... 1 Service and Repair... Chapter 3 Quick Setup 3... Chapter Overview... 7 3... Initial Setup... 7 Chapter 4 INVOS 5100C Description 4... Chapter Overview... 9 4... Principle of Operation... 9 4... Specifications... 4... 1 Physical... 9 4... 2 Operational... 4... 3 Electrical... 10 4... 4 Environmental Requirements... 4... 5 Default Settings... 11 4... 6 Additional... 12 4... System Diagram... 13 4... Display Screens... 4 4... 1 Welcome Screen ... 4 4... 2 Start Screen, Navigation Bar, Key Panel and Software Version... 5 4... 3 Patient Identifier Screen... 16 4... 4 Main Screen... 4... 5 User Configuration Screen ... 9 4... 6 Event Mark List Screen... 20 4... 7 Baseline Reset Screen... 4... 8 Channel Inactivity Screen... 4... 9 RS-232 Digital Output Format Selection Screen... 22 4... 10 Tabular Trends Screen... 4... 11 Case Archive File List Screen... 25 4... 11... Data File Name Format... 25 4... 12 Review Screen... 5 Chapter 5 Installation 5... Chapter Overview... 5... Unpacking ... 7 5... Serial Numbers ... 27 5... Installation ... 5... Digital Output Port ... 5... VGA Output Port ... 9 5... Potential Equalization Connector ... 9 5... Alarm Speaker... 29 5... Cooling Fan ... 5... AC Input and Fuse ... 9 5... USB Port ... 9 5... Accessories ... 0 5... Preamplifier ... 1 5... Reusable Sensor Cable... 32 5... Adult and Pediatric SomaSensor Application ... 32 5... SomaSensor Pre-use Check... 5... SomaSensor Lot Number... 3 5... SomaSensor Cerebral Site Selection... 33 5... SomaSensor Somatic Site Selection... 5... Patient Prep ... 33 5... SomaSensor Placement ... 34 5... Care of and Removing the SomaSensor... 5... Infant/Neonatal OxyAlert NIRSensor Application ... 5 5... OxyAlert NIRSensor Pre-use Check... 5 5... OxyAlert NIRSensor Lot Number... 35 5... OxyAlert NIRSensor Cerebral Site Selection... 5... OxyAlert NIRSensor Somatic Site Selection... 5... Patient Prep ... 35 5... OxyAlert NIRSensor Placement ... 5... Monitoring with the OxyAlert NIRSensor... 6 5... Care of and Removing the OxyAlert NIRSensor... 6 5... When INVOS System is Part of a Medical Monitoring System... 7 Chapter 6 Operating the INVOS System 6... Chapter Overview... 6... INVOS System Pre-use Check... 9 6... Operational Modes... 9 6... Date, Time and Patient Identifier Settings... 6... 1 Date ... 40 6... 1... Day... 0 6... 1... Month... 6... 1... Year... 0 6... 2 Time... 40 6... 2... Hours... 0 6... 2... Minutes... 6... 2... Seconds... 6... 3 Patient Identifier... 1 v

INVOS Operations Manual 5100C Rev B

INVOS™ System Inservice Guide for Neonatal Use 1 INVOS System Inservice Guide for Neonatal Use Key Terms rSO2: Regional oxygen saturation INVOS™: In Vivo Optical Spectroscopy Cerebral Application: Brain area measurement Somatic Application: Tissue area of measurement 2 INVOS System Inservice Guide for Neonatal Use

INVOS System Inservice Guide for Neonatal Use

INVOS™ System Inservice Guide for Pediatric Use INVOS System Inservice Guide for Pediatric Use The INVOS™ System: A Window to Perfusion Adequacy The noninvasive INVOS™ System reports the venous-­weighted regional hemoglobin oxygen saturation (rSO2) in tissue under the sensor keys, reflecting the hemoglobin bound oxygen remaining after tissues have taken what they need... ecreases in this venous reserve indicate increased ischemic risk and compromised tissue perfusion... Distal Detector Proximal Detector LED Emitter The INVOS™ System uses two depths of light penetration to subtract out surface data, resulting in a regional oxygenation value for deeper tissues... 2 INVOS System Inservice Guide for Pediatric Use

INVOS System Inservice Guide for Pediatric Use